MAUDE Adverse Event Report: SYNTHES PRODUKTIONS GMBH 10MM TI CANN TIBIAL NAIL-EX W/PROX BEND 375MM-STERILE; NAIL, FIXATION, BONE

Model Number	04.034.455S
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Nonunion/Delayed-union Bone Fracture (2369); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Complainant part is not expected to be returned for manufacturer review/investigation.Manufacturing location: (b)(4).Manufacturing date: 25-oct-2019.Expiration date: 30-sep-2028.Part number: 04.034.455s, 10mm ti cann tibial nail - ex w/prox bend 375mm ¿ sterile.Lot number: 21p2929 (sterile).Lot quantity: 6.Production order traveler met all inspection acceptance criteria.Inspection sheet, in-process / inspect dimensional / fina met all inspection acceptance criteria.Packaging label log (pll) was reviewed and determined to be conforming.Packaging bom was reviewed and determined to be conforming with no deviations to normal packaging identified.Scn 16813 by ethicon (abq) was reviewed and determined to be conforming.This lot met all dimensional, visual, sterility and packaging criteria at the time of release with no issues documented during the manufacture that would contribute to this complaint condition.Component part(s) reviewed: component parts were not reviewed as the reported complaint condition of ¿removal due to infected union¿ does not indicate breakage of the nail.Therefore, review of the raw materials would not be pertinent to the reported complaint condition.Manufacturing location: (b)(4).Manufacturing date: 25-oct-2019.Expiration date: 30-sep-2028.Part number: 04.034.455s, 10mm ti cann tibial nail - ex w/prox bend 375mm ¿ sterile.Lot number: 21p2929 (sterile).Lot quantity: 6.Production order traveler met all inspection acceptance criteria.Inspection sheet, in-process / inspect dimensional / final met all inspection acceptance criteria.Packaging label log (pll) lppf was reviewed and determined to be conforming.Packaging bom was reviewed and determined to be conforming with no deviations to normal packaging identified.Scn 16813 by ethicon (abq) was reviewed and determined to be conforming.This lot met all dimensional, visual, sterility and packaging criteria at the time of release with no issues documented during the manufacture that would contribute to this complaint condition.Component part(s) reviewed: component parts were not reviewed as the reported complaint condition of ¿removal due to infected union¿ does not indicate breakage of the nail.Therefore, review of the raw materials would not be pertinent to the reported complaint condition.(b)(4).Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
It was reported that on (b)(6) 2021 that the patient underwent the removal of implants due to an infected nonunion of the right tibia.All devices were removed successfully.There were no broken implants.There was no surgical delay and the procedure was completed successfully.The original date of implant was (b)(6) 2020.This report is for one (1) 10mm ti cann tibial nail-ex w/prox bend 375mm-sterile.This is report 6 of 6 for (b)(4).

• Brand Name: 10MM TI CANN TIBIAL NAIL-EX W/PROX BEND 375MM-STERILE
• Common Device Name: NAIL, FIXATION, BONE
• Manufacturer (Section D): SYNTHES PRODUKTIONS GMBH; muracherstrasse 3; bettlach 2544 ; SZ 2544
• MDR Report Key: 12204806
• Report Number: 9612488-2021-00007
• Device Sequence Number: 3509488
• Product Code: JDS
• UDI-Device Identifier: 10886982095268
• UDI-Public: 10886982095268
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• PMA/510(K) Number: K040762
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 04.034.455S
• Device Catalogue Number: 04.034.455S
• Device Lot Number: 21P2929
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/22/2021
• Initial Report FDA Received Date: 07/21/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Weight: 113